Complying With Final Rule Revising the Common Rule for Clinical Trials and Human Research
Recording of a 90-minute CLE webinar with Q&A
Conducted on Tuesday, February 28, 2017
Recorded event now available
This CLE webinar will provide guidance to counsel for navigating the changes to the Common Rule for clinical trials and human subjects research. The panel will examine the practical impact for stakeholders, such as hospitals, research organizations and drug manufacturers, and will outline compliance strategies to meet the new requirements.
On Jan. 19, 2017, the U.S. Department of Health and Human Services (HHS) and 15 other federal departments and agencies published a final rule to revise the Federal Policy for the Protection of Human Subjects (the Common Rule), which governs research involving human subjects. The majority of the rule’s provisions take effect in Jan. 2018.
The Common Rule has been in place since 1991, and the revisions provide a regulatory update in light of the many changes in the healthcare and life sciences industries since that time. The final rule addresses issues concerning informed consent, secondary research use of information and biospecimens, harmonization with the HIPAA Privacy Rule, review of multi-site research, and more.
Attorneys advising stakeholders in healthcare and the life sciences, including drug and device manufacturers, hospitals, academic medical centers, universities and medical schools, and institutional review boards, must fully understand the scope and complexity of the changes to the Common Rule to ensure clients are in full compliance.
Listen as our authoritative panel examines the changes to the Common Rule for clinical trials and human research. The panel will provide guidance on the new requirements and discuss the impact on stakeholders involved in clinical trials and human research. The panel will outline compliance strategies to meet the new requirements.
- Common Rule changes
- Impact on the regulatory landscape
- What providers and counsel need to do to ensure compliance
The panel will review these and other key issues:
- How do the revisions to the Common Rule change the requirements for human subjects research, including clinical trials?
- What will the practical impact be on organizations involved in clinical trials or human research?
- What steps must healthcare industry stakeholders take to ensure compliance by Jan. 2018?
Abram S. Barth, Esq.
Ropes & Gray,
Mr. Barth has a wide range of experience counseling on FDA regulation, with a particular focus on medical devices, combination products and clinical research. He formerly worked in the FDA’s Office of Chief Counsel, most recently as Associate Chief Counsel, serving as Team Leader of the Device Practice Group. Mr. Barth has significant experience advising clients on the life cycle of medical devices, including clinical trials, premarket submissions, advertising and promotion, quality system regulation, medical device reporting, and postmarket surveillance and studies, as well as the premarket and postmarket regulation of combination products.
Emily Marcus Levine, Senior Attorney
U.S. Department of Health and Human Services,
Ms. Levine is a Senior Attorney with the Public Health Division of the Office of the General Counsel, U.S. Department of Health and Human Services, where she has practiced public health law since 1999. Ms. Levine has provided legal advice to the Office for Human Research Protections since 2015 and was a key participant in HHS’s finalization of the final rule that amended the Common Rule. Ms. Levine also specializes in legal issues relating to organ transplantation and is an expert on vaccine injury compensation and liability.
Laura Odwazny, Senior Attorney
U.S. Department of Health and Human Services,
Ms. Odwazny’s primary client is the Office for Human Research Protections, which interprets and enforces the HHS regulations that provide protections for human research subjects. Ms. Odwazny also currently advises the Presidential Commission for the Study of Bioethical Issues and the HHS Office of Global Affairs. Throughout her 16 years with the Office of the General Counsel, Ms. Odwazny has provided legal advice to various other agencies within HHS, including the Office of the Assistant Secretary for Health, the Program Support Center Division of FOIA Services, the Health Resources and Services Administration, and the Substance Abuse and Mental Health Administration. Ms. Odwazny has served as an adjunct professor at American University Washington College of Law, teaching “The Law and Ethics of Human Subjects Research,” and currently teaches “Compliance in Research” for the University of Pittsburgh School of Law Health Care Compliance Certificate program.
David Peloquin, Esq.
Ropes & Gray,
Mr. Peloquin works with the firm’s Corporate Department, primarily on healthcare matters, and particularly in the area of clinical research and health data privacy. Prior to attending law school, he worked as a project manager for a leading supplier of electronic medical records. Mr. Peloquin is a frequent author and lecturer on clinical research/human subject protection issues, among others.
CLE On-Demand - Streaming Video
Includes recorded streaming video of full program plus PDF handouts.
On-demand is the only recorded format recognized for CLE credits in DE, IN, KS, LA, MS, NC, OH, OK, SC, TN, VA, WI.
AK, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN*, KS, KY, LA, ME, MN, MO, MT, NC, ND, NH**, NJ, NM, NV, NY, OH*, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY (Note: Some states restrict CLE eligibility based on the age of a program. Refer to our state CLE Map for additional information.)
*Only available for attorneys admitted for more than two years. For OH CLE credits, only programs recorded within the current calendar year are eligible - contact the CLE department for verification.
**NH attendees must self-determine if a program is eligible for credit and self-report their attendance.
CLE On-Demand Video $297.00
Includes full event recording plus handouts.
Strafford is an approved provider and self-study CLE credit is available in most states.
AK, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, KY, ME, MN, MO, MT, ND, NJ, NM, NY, OR, PA, TN, TX, UT, VT, WA, WV, WY (Note: Some states restrict CLE eligibility based on the age of a program. Refer to our state CLE Map for additional information.)
Strafford will process CLE credit for one person on each recording.
Additional copies of a recording can be purchased at a discount. Please call Strafford Customer Service toll-free at 1-800-926-7926 ext 10 or email firstname.lastname@example.org to place your order.
Recorded Webinar Download $297.00
Recorded Audio Download (MP3) $297.00
DVD (Slide Presentation with Audio) $297.00 plus $9.45 S&H
Strafford webinars offer several options for participation: online viewing of speaker-controlled PowerPoint presentations with audio via computer speakers or via phone; or audio only via telephone (download speaker handouts prior to the program). Please note that our webinars do not feature videos of the presenters.
CLE Credits By State
Well prepared and well presented information.
Quinlivan & Hughes
I appreciated that the program’s content was current and had great speakers.
Fowler White Boggs
The speakers were well prepared and knowledgeable.
San Francisco General Hospital
I enjoyed the programs content and the speaker's perspectives.
Wade Goldstein Landau & Abruzzo
The program included very informative information on an important subject.
Jamie L. Webb
Baker Manock & Jensen
Health Law Advisory Board
Fredrikson & Byron
Faegre Baker Daniels
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo
Wyatt, Tarrant & Combs
McDermott Will & Emery
Foley & Lardner
Foley & Lardner
Buchanan Ingersoll & Rooney
Drinker Biddle & Reath
Strafford webinars are backed by our 100% Unconditional Money-Back Guarantee: if you are not satisfied with any of our products, simply let us know and get a full refund. For more information regarding complaints and refunds, please contact us at 1-800-926-7926 ext 10. Complaints regarding this program can be submitted via the course evaluation found in the “Thank you” e-mail at the end of the course.